Data from FDA (Food and Drug Administration, USA) - Curated by Marshall Pearce - Last updated 17 April 2017

Indication(s)

BOOSTRIX is a vaccine indicated for active booster immunization against tetanus, diphtheria, and pertussis. BOOSTRIX is approved for use as a single dose in individuals 10 years of age and older. (1)

Full Prescribing information

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Advisory information

contraindications

• Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any tetanus toxoid-, diphtheria toxoid-, or pertussis antigen-containing vaccine or to any component of BOOSTRIX. (4.1)
• Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous pertussis antigen-containing vaccine. (4.2)

Special warnings and precautions
• The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions. (5.1)
• If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the risk of Guillain-Barré syndrome may be increased following a subsequent dose of tetanus toxoid-containing vaccine, including BOOSTRIX. (5.2)
• Syncope (fainting) can occur in association with administration of injectable vaccines, including BOOSTRIX. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope. (5.3)
• Progressive or unstable neurologic conditions are reasons to defer vaccination with a pertussis-containing vaccine, including BOOSTRIX. (5.4)
• Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of a tetanus toxoid-containing vaccine should not receive BOOSTRIX unless at least 10 years have elapsed since the last dose of a tetanus toxoid-containing vaccine. (5.5)
Adverse reactions
• Common solicited adverse events (≥15%) in adolescents (10 to 18 years of age) were pain, redness, and swelling at the injection site, increase in arm circumference of injected arm, headache, fatigue, and gastrointestinal symptoms. (6.1)
• Common solicited adverse events (≥15%) in adults (19 to 64 years of age) were pain, redness, and swelling at the injection site, headache, fatigue, and gastrointestinal symptoms. (6.1)
• The most common solicited adverse event (≥15%) in the elderly

Usage information

Dosing and administration
A single intramuscular injection (0.5 mL). (2.2)
Use in special populations
• Safety and effectiveness of BOOSTRIX have not been established in pregnant women. (8.1)
• Register women who receive BOOSTRIX while pregnant in the pregnancy registry by calling 1-888-452-9622. (8.1)

Interactions

• In subjects 11 to 18 years of age, lower levels for antibodies to pertactin were observed when BOOSTRIX was administered concomitantly with meningococcal conjugate vaccine (serogroups A, C, Y, and W-135) as compared with BOOSTRIX administered first. (7.1)
• In subjects 19 to 64 years of age, lower levels for antibodies to FHA and pertactin were observed when BOOSTRIX was administered concomitantly with an inactivated influenza vaccine as compared with BOOSTRIX alone. (7.1)
• Do not mix BOOSTRIX with any other vaccine in the same syringe or vial. (7.1)

More information

Category Value
Authorisation number BLA125106
Orphan designation No
Product NDC 50090-1377
Date First Approved 24-07-2009
Marketing authorisation holder GlaxoSmithKline Biologicals